A Multicenter Randomized Controlled Phase II Trial of Neoadjuvant mFOLFOXIRI Versus Routine Chemoradiotherapy in the EMVI Positive Locally Advanced Rectal Cancer (TRICHEMO)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- MFS
研究概览
简要总结
Extramural Vascular Invasion Positive(EMVI+) is a high risk of distant metastasis for locally advanced rectal cancer(LARC) after resection. The study is to evaluate the efficacy and safety of FOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to the efficacy of standard Chemoradiotherapy (CRT).
详细描述
It is an investigator-initiated, multicentered, randomized controlled clinical study to evaluate the efficacy and safety of mFOLFOXIRI as neoadjuvant chemotherapy alone for EMVI+ LARC in contrast to standard chemoradiotherapy. Patients of LARC with EMVI+ evaluated by pelvic magnetic resonance imaging (MRI) are enrolled in this trial. All patients will be randomized divided into two groups.
Experimental group will receive 3 cycles of mFOLFOXIRI, followed to be performed MRI to assess clinical response. If the tumor response is good enough (partial response or complete response), the patient will receive another 3 cycles of mFOLFOXIRI then surgery. On the contrary, if the tumor shows poor response (stable disease or progressive disease) or with mesorectal fascia-positive or ycT4a/b after re-evaluation, radiotherapy will be performed combined with capecitabine before operation. Control group will receive standard capecitabine based chemoradiotherapy.
Patients with mesorectal fascia-positive or ycT4a/b after re-evaluation would receive radiation before surgery, whereas responders would have immediate total mesorectal excision (TME). All patients will receive 4 cycles of XELOX as adjuvant chemotherapy after TME.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 to 70 years at diagnosis;
- •ECOG status 0-2;
- •Diagnosis of rectal adenocarcinoma(Distal border of the tumor must be located < 12 cm from the anal verge);
- •MRI examination diagnosed EMVI-positive;
- •Tumor amenable to curative resection;
- •Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment: (1) Neutrophilic granulocytes ≥ 3.0 x10^9/L, Platelet count ≥ 75 x 10^9/L, Hemoglobin (Hb) ≥ 90g/L; (2) bilirubin ≤1.5 x the upper limit of normal (ULN),Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN; (3) Serum creatinine ≤ 1.5 x ULN.No renal disease that would preclude study treatment or follow-up
- •Signed informed consent; able to comply with study and/or follow- up procedures
排除标准
- •Hypersensitivity to fluorouracil, oxaliplatin or irinotecan;
- •Patient had received pelvic radiotherapy;
- •Patient had received systemic chemotherapy;
- •History of invasive colon or rectal malignancy, regardless of disease-free interval;
- •Had metastatic disease;
- •Patient had second malignant disease within 5 years;
- •Uncontrolled co-morbid illnesses or other concurrent disease;
- •Patients refused to signed informed consent.
- •Pregnant and Nursing women
研究组 & 干预措施
mFOLFOXIRI
Patients receive 6 cycles of mFOLFOXIRI
干预措施: mFOLFOXIRI (Drug)
Chemoradiotherapy(CRT)
Patients receive standard chemoradiotherapy
干预措施: Chemoradiotherapy (Combination Product)
结局指标
主要结局
MFS
时间窗: 3 years
metastasis free survival
次要结局
- DFS(3 years)
- Tumor downstaging rate(2 years)
- RFS(3 years)
- OS(5 years)
- pCR(2 years)
- Reported Adverse events(2 years)
研究者
Guosheng Wu
Chief physician
First Affiliated Hospital of Zhejiang University